510(k) · Cleared
ClearedEpoch 2000 Neurological Workstation
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Axon Systems, Inc. · GWF Stimulator, Electrical, Evoked Response
Cleared on Nov 20, 1997 as substantially equivalent to K900482 (Axon Systems, Inc., 1990) and 3 other predicates after a 188-day review. Its family tree reaches back 1 generation to 1984. 1 of the 469 devices in its family, counting itself, has a Class I recall. 464 later devices descend from it.
- Decided
- Nov 20, 1997
- Review
- 188 days
- Class
- Class II
- Product code
- GWF
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 1 generation to K842956 (1984). 4 ancestors in all. 464 later devices descend from it, 1 citing it directly. 1 of the 469 devices in this family, counting this one, has a Class I recall.
- Root · 1 generation backK842956 Nicolet VikingNicolet Biomedical Instruments · 1984
- This deviceK971819 Epoch 2000 Neurological WorkstationAxon Systems, Inc. · 1997
- Descendant · cites it directly · 463 of its ownK022785 Epoch XP Neurological Workstation; Epoch XP Lite Neurological…Axon Systems, Inc. · 2002
- Descendant · 2 generations on · 462 of its ownK032741 Epochxp Neurological Workstation,Epochxp Lite Neurological WorkstationAxon Systems, Inc. · 2003
- Descendant · 3 generations on · 460 of its ownK050798 Eclipse Neurological WorkstationAxon Systems, Inc. · 2005
- Descendant · 4 generations on · 450 of its ownK061113 OrthomonAxon Systems, Inc. · 2006
- Descendant · 4 generations on · 426 of its ownK061639 Eclipse TCD Neurovascular Workstation; Elclipse Neurological…Axon Systems, Inc. · 2006
Showing 5 of 464 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K211616 ExcelsiusHub10 generations on · 2021
Most influential descendants
Showing 5 of 464 · See all- K022785Epoch XP Neurological Workstation; Epoch XP Lite Neurological WorkstationAxon Systems, Inc. · 2002 · cites it directly463descendants
- K032741Epochxp Neurological Workstation,Epochxp Lite Neurological WorkstationAxon Systems, Inc. · 2003 · 2 generations on462descendants
- K050798Eclipse Neurological WorkstationAxon Systems, Inc. · 2005 · 3 generations on460descendants
- K061113OrthomonAxon Systems, Inc. · 2006 · 4 generations on450descendants
- K061639Eclipse TCD Neurovascular Workstation; Elclipse Neurological Workstation with TCD and…Axon Systems, Inc. · 2006 · 4 generations on426descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K842956 | Nicolet Viking | Nicolet Biomedical Instruments | 1984 | — |
| 0 (this device) | K971819 | Epoch 2000 Neurological Workstation | Axon Systems, Inc. | 1997 | — |
| +1 | K022785 | Epoch XP Neurological Workstation; Epoch XP Lite Neurological Workstation | Axon Systems, Inc. | 2002 | — |
| +2 | K032741 | Epochxp Neurological Workstation,Epochxp Lite Neurological Workstation | Axon Systems, Inc. | 2003 | — |
| +3 | K050798 | Eclipse Neurological Workstation | Axon Systems, Inc. | 2005 | — |
| +4 | K061113 | Orthomon | Axon Systems, Inc. | 2006 | — |
| +4 | K061639 | Eclipse TCD Neurovascular Workstation; Elclipse Neurological Workstation with… | Axon Systems, Inc. | 2006 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1990 | 1 | 0 |
| 1992 | 1 | 0 |
| 1995 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 1 | 0 |
| 2003 | 1 | 0 |
| 2005 | 1 | 0 |
| 2006 | 2 | 0 |
| 2007 | 1 | 0 |
| 2011 | 3 | 0 |
| 2012 | 3 | 0 |
| 2013 | 4 | 0 |
| 2014 | 4 | 0 |
| 2015 | 8 | 0 |
| 2016 | 9 | 0 |
| 2017 | 17 | 0 |
| 2018 | 20 | 0 |
| 2019 | 31 | 0 |
| 2020 | 22 | 0 |
| 2021 | 42 | 1 |
| 2022 | 48 | 0 |
| 2023 | 64 | 0 |
| 2024 | 62 | 0 |
| 2025 | 64 | 0 |
| 2026 | 57 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
1 device in this family has a Class I recall. A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new GWF device
- #1 K263010 ISIS Headboxes, ISIS Neurostimulator, ISIS…score 17.5 · 19 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (4)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K900482 | Software & Hardware Addition to Sentinel-4 EegSummary page 3…ally equivalent to the predicate devices noted. The Epoch 2000 is similar is concept and function to our original product, the Sentinel-4 EEG/EP Intraoperative Monitor (K900482A), a class II device. This instrument is also used to monitor brain function and neurological activity utilizing EEG and multiple… | 1990 |
| * | K914571 | Neurotrac IISummary page 2…g Equivalent Predicate Devices Device - Axon Systems | Axon Systems Moberg Nicolet Epoch 2000 Sentinel-4 Medical Viking IV DC# 900482A | Neurotrac II | DC# K842956 3 DC# K914571 | DC# K950270 Cerebral ischemia Yes Yes Yes Yes Show changes in EEG Yes Yes Yes Yes due to neuroactive drugs Long term coma Yes Y… | 1992 |
| * | K842956 | Nicolet VikingSummary page 2…e of Monitoring Equivalent Predicate Devices Device - Axon Systems | Axon Systems Moberg Nicolet Epoch 2000 Sentinel-4 Medical Viking IV DC# 900482A | Neurotrac II | DC# K842956 3 DC# K914571 | DC# K950270 Cerebral ischemia Yes Yes Yes Yes Show changes in EEG Yes Yes Yes Yes due to neuroactive drugs Long t… | 1984 |
| * | K950270 | Nmi SoftwareSummary page 2…redicate Devices Device - Axon Systems | Axon Systems Moberg Nicolet Epoch 2000 Sentinel-4 Medical Viking IV DC# 900482A | Neurotrac II | DC# K842956 3 DC# K914571 | DC# K950270 Cerebral ischemia Yes Yes Yes Yes Show changes in EEG Yes Yes Yes Yes due to neuroactive drugs Long term coma Yes Yes Yes Seizure… | 1995 |
What descends from it? (464)
See all 4641 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K022785 | Epoch XP Neurological Workstation; Epoch XP Lite Neurological Workstation | 2002 | 463 |
Has anything in its family been recalled? (1 Class I)
No FDA recall names this device.
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K211616ExcelsiusHubGlobus Medical, Inc. · 2021 · 10 generations on · ◆ in the 2021 descendants bar of FIG. 11 Class I recall
What does this lineage say?
- None of the 4 ancestors has a recall.
- Of its descendants, K022785 (Axon Systems, Inc., 2002) has gone furthest, with 463 descendants of its own.
How does its category compare?
All GWF devicesGWF Stimulator, Electrical, Evoked Response: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · GWF
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · GWF
92in 2024
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · GWF
2so far in 2026, the most since 2007
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · GWF
1,034in 2025
MAUDE reports naming product code GWF, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 3 | 69 | 0 | 2 |
| 2008 | 2 | — | 0 | 1 |
| 2009 | 5 | 178 | 0 | 1 |
| 2010 | 3 | 269 | 0 | 4 |
| 2011 | 2 | — | 0 | 10 |
| 2012 | 4 | 230 | 1 | 44 |
| 2013 | 3 | 174 | 0 | 89 |
| 2014 | 1 | — | 0 | 25 |
| 2015 | 2 | — | 1 | 22 |
| 2016 | 1 | — | 0 | 20 |
| 2017 | 3 | 169 | 0 | 60 |
| 2018 | 0 | — | 0 | 58 |
| 2019 | 1 | — | 0 | 94 |
| 2020 | 1 | — | 0 | 65 |
| 2021 | 2 | — | 0 | 55 |
| 2022 | 2 | — | 0 | 45 |
| 2023 | 2 | — | 0 | 150 |
| 2024 | 4 | 92 | 0 | 854 |
| 2025 | 1 | — | 0 | 1,034 |
| 2026 | 3 | 125 | 2 | — |
What is it indicated for?
The Epoch 2000 is intended for use in the operating room and critical care areas for neurological monitoring and assessment. The instrument uses EEG, evoked potentials and EMG techniques to provide the health care professionals with information to help access a patient’s neurological status during surgery or long-term monitoring in the ICU.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K971819 · printed Nov 6, 2026
Cite this page
510(k) Report. “K971819: Epoch 2000 Neurological Workstation.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K971819
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026